Objective

The informed consent (IC) process allows the subject to voluntarily decide whether or not his/her participation in research. Generally, ICs are difficult to read documents that do not include all stakeholders’ perceptions. Therefore, informative IC should be a process that include needed information under a gender and age perspective, more importantly if these are vulnerable populations. The relationship between science and society should favour the engagement inclusion of citizens in the informed consent process, and this must be done with especial attention to gender and ethics considerations. The IC process should also improve health literacy in the citizens. The I-CONSENT project presents a simple work plan structure with a WP1 aimed to analyze baseline knowledge of IC, WP2 presenting innovative solutions and WP3 proposing new guidelines, disseminated in WP4. For this i-CONSENT consortium presents a multi-stakeholder community of partners from academia, public health, patient organizations, clinicians and private sector, including pharma and SMEs, and a set of activities that will maximize the collection (workshops) and dissemination (communication plan) of information. Specifically, and to ensure alignment with the Topic scope, the project will use a selection of 3 different vaccines as study frame to improve guidelines for informed consents. These do focus on vulnerable age populations with very special emphasis on gender: Human Papilloma Virus (HPV) vaccines (preadolescent and adolescents), Meningitis (adults) and Respiratory Syncitial Virus (pregnant women). Besides Gender and Ethic issues as centre of the proposal, the project will consider the interaction of age and gender, with its specifics as comprehension of medical information, oral and written language, and availability and use of new technologies will also be considered.

Periodic Reporting for period 1 - I-CONSENT (Improving the guidelines for Informed Consent, including vulnerable populations, under a gender perspective)

The autonomy of the subject to decide his/her participation in clinical research (CR) is of major importance. Historically, the participation of subjects in CR hasn’t always been voluntary. The Declaration of Helsinki from the World Medical Association provided the foundations of ethical research.Informed consent (IC) is vital, enabling the subject to voluntarily decide whether or not participate in research. The IC objectives are not always aligned for all the stakeholders involved in the research process. In general, the IC is prepared by only one of the stakeholders, mainly considering their objectives without taking into account the views of the other stakeholders or the patient’s characteristics. Currently, low participation of women in CR is one of the largest inequities in medicine and new ways of communicating IC, under a gender perspective, are required.i-CONSENT understands IC as a process where people become increasingly literate in health, in which essential information about a clinical trial is clearly presented and easy to understand, and different ways of communicating among all stakeholders involved in the research are enabled. The gender dimension should also be integrated into the process.The Informed Consent Process (ICP) starts from the first contact with the potential participant until the end of the study (figure 1). After the subject has shown interest in the research, they will have a conversation with the health professional during which all relevant information about the study will be discussed and their questions will be resolved, using understandable language and innovative communication tools. At this point they will make a decision regarding their participation. After the patient's enrolment comes the intervention. During this process, steps will be made to monitor the procedure and resolve any doubts that arise (the participant can also dissent to participate in any moment). Feedback from patients and the research team are collected and analysed to assess the process, provide improvements and generate a new starting point for future research. Figure 1. Informed Consent Process [SEE IMAGE] ObjectivesThe main objective of i-CONSENT is to develop comprehensive guidelines on how to present IC to citizens in a way which facilitates participation in research. To achieve this objective, the project will pursue 6 specific objectives:1. To assess all stakeholders’ needs in relation to the IC.2. To identify gaps, barriers and challenges, and prioritise needs, requirements and areas for action in the process of IC.3. To analyse the risks and opportunities provided by the use of digital technologies, aiming to produce a set of ICT-based strategies that enable to overcome the challenges and barriers in the process of IC.4. To develop tailored strategies to inform the development of informed consent.5. To analyse the ethical and legal aspects of IC in relation to social media use.6. To create and validate guidelines to develop comprehensive IC that improves citizens’ participation in research.

"WP1: has finished successfully. Ethical, legal and literature reviews, workshops and seminars have been held. Work carried out has allowed the collection and analysis of information from different disciplines and the inclusion of perspectives from different experts, patient organisations and interested parties in workshops.As a result, 7 deliverables have been submitted. They analyse the gender, age and multicultural perspectives of IC, including a scientific, legal and ethical review. They also incorporate other issues related to IC, such as socio-cultural, psychological and behavioural perspectives toward the ICP, ways of improving communication and increasing comprehension of IC, and the content and format of IC forms.5 communications have been presented in 3 congresses; 2 speeches were included in 2 different conferences; 8 workshops have been conducted. WP2: All tasks have already started. It analyses the use of new technologies and the opportunities they present to the health sector, particularly within the ICP, identifying strategies to improve participation, health literacy and communication. The analysis of the latest trends in eHealth / mHealth and initiatives relevant to eConsent in health care systems around the world is already finished. A seminar about the involvement of subjects belonging to ethnic and religious minorities in clinical trials has been organised in task 2.6.WP3: has just started. 1 seminar about the validation of informed consent in clinical trials has been organised.WP4: the visual identity of the project has been developed, Twitter (@ICONSENTEU) and LinkedIn (https://www.linkedin.com/company/i-consent-project/) accounts created and the website (https://i-consentproject.eu/) launched and continuously updated. Basic materials have been created (leaflet, poster and roll-up). The project has participated in two social media campaigns: #patientshavepower and #healthliteracymonth. Internal newsletters have been created to inform about the progress of each WP and about different news and events related to the project. For the external newsletter, a stakeholder map is being developed. 2 newsletter design proposals have been produced and are pending internal approval.The project has been presented in 2 scientific conferences and in institution presentations in GSK and FISABIO.WP5: The tasks carried out have been very important to create and consolidate a group identity. Numerous meetings have been held, ensuring smooth communication between the partners. Several templates have been prepared to unify concepts and procedures. The Management Plan and the Data Management Plan have been prepared and submitted. Different risks have been faced during this period. 3 face-to-face coordination meetings and 5 steering committees meetings have been held during this period.WP6: Two deliverables have been submitted. D6.4 describes the general procedures that will be applied to the project with the data. D6.1 contains the ethical requirements of the research tasks involving humans (excluding WP3)."

7 reviews (systematic, narrative and ethical/legal) analysing the state of the art have been completed, corresponding to 6 deliverables of WP1 already submitted and task 2.2 (report under internal review). WP2 includes other reviews that are still in the early phases of development or have not yet started. D1.1 includes a review of international guidelines and a narrative review of scientific studies to identify and analyse methods, techniques and strategies associated with the improvement of IC in CR. Reviews completed in D1.2 and D1.3 will be useful for applying a gender and age perspective to the ICP.The review in D1.5 analyses the legal issues concerning IC in translational and CR. A review in task 1.4 includes the different perspectives of the largest religions about clinical research and IC. D1.7 includes a review on socio-cultural and psychological perspectives relevant to the ICP and participation in CR. Both reviews will be useful to apply a multicultural approach. All these reviews will enable the design of new strategies to improve the IC, giving importance to the whole process and increasing knowledge of how to tailor it to the participants’ characteristics. This will enable a more innovative ICP, which promotes gender equality in CR in order to decrease gender inequities in medicine.

Figure 1. Informed Consent Process (to add in the Summary of the context and overall objectives)